Comparative Efficacy of Ovule vs Tablet
Primary Purpose
Clotrimazole, Ovulen, Vulvovaginal Candidiasis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Clotrimazole, vaginal ovule
Clotrimazole, vaginal tablet
Sponsored by
About this trial
This is an interventional treatment trial for Clotrimazole focused on measuring Clotrimazole, Ovule, Tablet, Vulvovaginal candidiasis, Non-inferiority
Eligibility Criteria
Inclusion Criteria:
- Non-pregnant females aged at least 14 years in Germany or at least 16 years in Russia and not older than 50 years.
- Subjects presenting a symptomatic vulvovaginal yeast infection confirmed by microscopic evaluation (wet mount preparation).
- Subjects must be cooperative, able to understand the requirements of the trial participation, and willing to participate in the trial. For adolescents the informed consent has to be provided to a legal representative in addition.
- Subjects of childbearing potential must use an acceptable method of contraception. Hormonal or oral contraceptive drugs, intra-uterine devices (IUD) and abstinence are considered acceptable methods of contraception.
- Negative saline smear for Trichomonas vaginalis
Exclusion Criteria:
- Subjects with known hypersensitivity to imidazoles or triazoles and their analogues.
- Subjects presenting a protozoan infection as confirmed by microscopic investigation.
- Pregnant, breast feeding or lactating subjects.
- Subjects with suspected bacterial vaginal infection.
- Subjects with abdominal pain, fever, or foul smelling vaginal discharge.
- Subjects who had a vaginal infection, or who had used an intravaginal or systemic antimycotic treatment within 60 days prior to visit 1.
- Subjects using or wishing to use intra-vaginal or systemic anti-infectives or systemic antifungal therapy during the trial.
- Subjects wishing to use contraceptive foams, creams, jellies, sponges, therapeutic ointments, condoms, diaphragms, and OTC vaginal products during treatment and 3 days thereafter (i.e. until day 4).
- Subjects unable to refrain from the use of vaginal tampons during treatment and for 3 days thereafter (i.e. until day 4).
- Subjects unable to refrain from the use of feminine hygiene products (e.g. douches, feminine deodorant products) for 2 weeks (i.e. from visit 1 until visit 2).
- Subjects suffering from chronic/recurrent vulvovaginal mycosis, defined as 4 or more mycologically proven symptomatic episodes during the last 12 months.
- Subjects suffering from diseases (e.g. diabetes, decreased cellular immunity) or being treated with drugs (e.g. immunosuppressants, corticosteroids, anti-infectives) which may predispose them to mycological infections.
- Subjects who received another investigational drug within 30 days before visit 1.
- Unwillingness to refrain from sexual activity during 3 days thereafter.
- Actual menstruation at visit 1 or expected menstruation within 4 days after visit 1.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Clotrimazole tablet (Canesten, BAY-B5097)
Clotrimazole ovule (Canesten, BAY-B5097)
Arm Description
Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0).
Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0).
Outcomes
Primary Outcome Measures
Percentage of Subjects With Overall Response at Visit 2 (Day 10 to 14)
Secondary Outcome Measures
Percentage of Subjects With Overall Response at Visit 3 (Week 6 to 8)
Percentage of Subjects With Clinical Cure at Visit 2 (Day 10 to 14)
Percentage of Subjects With Clinical Cure at Visit 3 (Week 6 to 8)
Percentage of Subjects With Mycological Cure at Visit 2 (Day 10 to 14)
Percentage of Subjects With Mycological Cure at Visit 3 (Week 6 to 8)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00755053
Brief Title
Comparative Efficacy of Ovule vs Tablet
Official Title
An Investigator-blinded, Active-controlled Phase 3 Study to Prove the Non-inferior Efficacy of a Clotrimazole Ovule (500 mg) Versus a Clotrimazole Vaginal Tablet (500 mg) in Vaginal Candidiasis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is focused to prove that the efficacy of a new Canesten formulation (ovule) is not inferior to the old Canesten formulation (tablet)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clotrimazole, Ovulen, Vulvovaginal Candidiasis
Keywords
Clotrimazole, Ovule, Tablet, Vulvovaginal candidiasis, Non-inferiority
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
466 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clotrimazole tablet (Canesten, BAY-B5097)
Arm Type
Active Comparator
Arm Description
Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0).
Arm Title
Clotrimazole ovule (Canesten, BAY-B5097)
Arm Type
Experimental
Arm Description
Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0).
Intervention Type
Drug
Intervention Name(s)
Clotrimazole, vaginal ovule
Intervention Description
Single intravaginal dose of 500 mg clotrimazole ovule at Visit 1 (Day 0).
Intervention Type
Drug
Intervention Name(s)
Clotrimazole, vaginal tablet
Intervention Description
Single intravaginal dose of 500 mg clotrimazole tablet at Visit 1 (Day 0).
Primary Outcome Measure Information:
Title
Percentage of Subjects With Overall Response at Visit 2 (Day 10 to 14)
Time Frame
10-14 days after treatment (=visit 2)
Secondary Outcome Measure Information:
Title
Percentage of Subjects With Overall Response at Visit 3 (Week 6 to 8)
Time Frame
6-8 weeks after treatment (=visit 3)
Title
Percentage of Subjects With Clinical Cure at Visit 2 (Day 10 to 14)
Time Frame
10-14 days after treatment (=visit 2)
Title
Percentage of Subjects With Clinical Cure at Visit 3 (Week 6 to 8)
Time Frame
6-8 weeks after treatment (=visit 3)
Title
Percentage of Subjects With Mycological Cure at Visit 2 (Day 10 to 14)
Time Frame
10-14 days after treatment (=visit 2)
Title
Percentage of Subjects With Mycological Cure at Visit 3 (Week 6 to 8)
Time Frame
6-8 weeks after treatment (=visit 3)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Non-pregnant females aged at least 14 years in Germany or at least 16 years in Russia and not older than 50 years.
Subjects presenting a symptomatic vulvovaginal yeast infection confirmed by microscopic evaluation (wet mount preparation).
Subjects must be cooperative, able to understand the requirements of the trial participation, and willing to participate in the trial. For adolescents the informed consent has to be provided to a legal representative in addition.
Subjects of childbearing potential must use an acceptable method of contraception. Hormonal or oral contraceptive drugs, intra-uterine devices (IUD) and abstinence are considered acceptable methods of contraception.
Negative saline smear for Trichomonas vaginalis
Exclusion Criteria:
Subjects with known hypersensitivity to imidazoles or triazoles and their analogues.
Subjects presenting a protozoan infection as confirmed by microscopic investigation.
Pregnant, breast feeding or lactating subjects.
Subjects with suspected bacterial vaginal infection.
Subjects with abdominal pain, fever, or foul smelling vaginal discharge.
Subjects who had a vaginal infection, or who had used an intravaginal or systemic antimycotic treatment within 60 days prior to visit 1.
Subjects using or wishing to use intra-vaginal or systemic anti-infectives or systemic antifungal therapy during the trial.
Subjects wishing to use contraceptive foams, creams, jellies, sponges, therapeutic ointments, condoms, diaphragms, and OTC vaginal products during treatment and 3 days thereafter (i.e. until day 4).
Subjects unable to refrain from the use of vaginal tampons during treatment and for 3 days thereafter (i.e. until day 4).
Subjects unable to refrain from the use of feminine hygiene products (e.g. douches, feminine deodorant products) for 2 weeks (i.e. from visit 1 until visit 2).
Subjects suffering from chronic/recurrent vulvovaginal mycosis, defined as 4 or more mycologically proven symptomatic episodes during the last 12 months.
Subjects suffering from diseases (e.g. diabetes, decreased cellular immunity) or being treated with drugs (e.g. immunosuppressants, corticosteroids, anti-infectives) which may predispose them to mycological infections.
Subjects who received another investigational drug within 30 days before visit 1.
Unwillingness to refrain from sexual activity during 3 days thereafter.
Actual menstruation at visit 1 or expected menstruation within 4 days after visit 1.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Freiburg
State/Province
Baden-Württemberg
ZIP/Postal Code
79106
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
80333
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
85356
Country
Germany
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
65929
Country
Germany
City
Fulda
State/Province
Hessen
ZIP/Postal Code
36037
Country
Germany
City
Wiesbaden
State/Province
Hessen
ZIP/Postal Code
65197
Country
Germany
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30459
Country
Germany
City
Osnabrück
State/Province
Niedersachsen
ZIP/Postal Code
49074
Country
Germany
City
Dortmund
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44319
Country
Germany
City
Krefeld
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47799
Country
Germany
City
Hamburg
ZIP/Postal Code
22159
Country
Germany
City
Hamburg
ZIP/Postal Code
22359
Country
Germany
City
Moscow
ZIP/Postal Code
117198
Country
Russian Federation
City
Moscow
ZIP/Postal Code
119002
Country
Russian Federation
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
City
Moscow
ZIP/Postal Code
127473
Country
Russian Federation
City
Moscow
ZIP/Postal Code
129090
Country
Russian Federation
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrialsregister.eu
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe
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Comparative Efficacy of Ovule vs Tablet
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